MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71339550
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr had been performed, the r3 0 deg xlpe acet lnr 32mm x 50mm broke and become dislodged.This adverse event was treated with a revision surgery performed on (b)(6) 2020, in which the r3 0 deg xlpe acet lnr 32mm x 50mm and oxinium fem hd 12/14 32mm +0 were replaced.Due to revision surgery, the patient currently experiences some level of pain and decreased range of motion daily.
Additional Manufacturer Narrative
Further review of this case indicates this is a duplicate report.The event in this report has been already reported under mdr no.(b)(4).All further communication for this event will be managed in that case, including a follow up report with the results of our investigation.We respectfully request to close the case as a duplicate and refer to the referenced case above.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 50MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12471519
• Report Number: 1020279-2021-06838
• Device Sequence Number: 4892393
• Product Code: JDI
• UDI-Device Identifier: 03596010598806
• UDI-Public: 03596010598806
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71339550
• Device Catalogue Number: 71339550
• Device Lot Number: 20GM02592
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention